Dilation instrument with navigation and distally located force sensor

ABSTRACT

A system includes a dilation catheter and a guide member. The dilation catheter includes a proximal end, a distal end, a dilator, a navigation sensor, and a force sensor. The dilator is positioned proximal to the distal end and is configured to transition between a non-dilated configuration and a dilated configuration. The navigation sensor is positioned distal to the dilator and is configured to cooperate with a guidance system and thereby provide signals indicating a position of the dilation catheter in three-dimensional space. The force sensor is positioned distal to the dilator and is configured to provide signals indicating a force encountered by the force sensor. The dilation catheter is configured to slide relative to the guide member. A distal portion of the guide member is sized and configured to fit in a nasal cavity of a patient.

This application is a continuation of U.S. patent application Ser. No.15/830,205, entitled “Dilation Instrument with Navigation and DistallyLocated Force Sensor,” filed Dec. 4, 2017, issued as U.S. Pat. No.10,864,046 on Dec. 15, 2020.

BACKGROUND

In some instances, it may be desirable to dilate an anatomicalpassageway in a patient. This may include dilation of ostia of paranasalsinuses (e.g., to treat sinusitis), dilation of the larynx, dilation ofthe Eustachian tube, dilation of other passageways within the ear, nose,or throat, etc. One method of dilating anatomical passageways includesusing a guide wire and catheter to position an inflatable balloon withinthe anatomical passageway, then inflating the balloon with a fluid(e.g., saline) to dilate the anatomical passageway. For instance, theexpandable balloon may be positioned within an ostium at a paranasalsinus and then be inflated, to thereby dilate the ostium by remodelingthe bone adjacent to the ostium, without requiring incision of themucosa or removal of any bone. The dilated ostium may then allow forimproved drainage from and ventilation of the affected paranasal sinus.A system that may be used to perform such procedures may be provided inaccordance with the teachings of U.S. Pub. No. 2011/0004057, entitled“Systems and Methods for Transnasal Dilation of Passageways in the Ear,Nose or Throat,” published Jan. 6, 2011, now abandoned, the disclosureof which is incorporated by reference herein. An example of such asystem is the Relieva® Spin Balloon Sinuplasty™ System by Acclarent,Inc. of Irvine, Calif.

A variable direction view endoscope may be used with such a system toprovide visualization within the anatomical passageway (e.g., the ear,nose, throat, paranasal sinuses, etc.) to position the balloon atdesired locations. A variable direction view endoscope may enableviewing along a variety of transverse viewing angles without having toflex the shaft of the endoscope within the anatomical passageway. Suchan endoscope that may be provided in accordance with the teachings ofU.S. Pub. No. 2010/0030031, entitled “Swing Prism Endoscope,” publishedFeb. 4, 2010, now abandoned, the disclosure of which is incorporated byreference herein.

While a variable direction view endoscope may be used to providevisualization within the anatomical passageway, it may also be desirableto provide additional visual confirmation of the proper positioning ofthe balloon before inflating the balloon. This may be done using anilluminating guidewire. Such a guidewire may be positioned within thetarget area and then illuminated, with light projecting from the distalend of the guidewire. This light may illuminate the adjacent tissue(e.g., hypodermis, subdermis, etc.) and thus be visible to the naked eyefrom outside the patient through transcutaneous illumination. Forinstance, when the distal end is positioned in the maxillary sinus, thelight may be visible through the patient's cheek. Using such externalvisualization to confirm the position of the guidewire, the balloon maythen be advanced distally along the guidewire into position at thedilation site. Such an illuminating guidewire may be provided inaccordance with the teachings of U.S. Pat. No. 9,155,492, entitled“Sinus Illumination Lightwire Device,” issued Oct. 13, 2015, thedisclosure of which is incorporated by reference herein. An example ofsuch an illuminating guidewire is the Relieva Luma Sentry™ SinusIllumination System by Acclarent, Inc. of Irvine, Calif.

Image-guided surgery (IGS) is a technique where a computer is used toobtain a real-time correlation of the location of an instrument that hasbeen inserted into a patient's body to a set of preoperatively obtainedimages (e.g., a CT or MRI scan, 3-D map, etc.) so as to superimpose thecurrent location of the instrument on the preoperatively obtainedimages. In some IGS procedures, a digital tomographic scan (e.g., CT orMRI, 3-D map, etc.) of the operative field is obtained prior to surgery.A specially programmed computer is then used to convert the digitaltomographic scan data into a digital map. During surgery, specialinstruments having sensors (e.g., electromagnetic coils that emitelectromagnetic fields and/or are responsive to externally generatedelectromagnetic fields) mounted thereon are used to perform theprocedure while the sensors send data to the computer indicating thecurrent position of each surgical instrument. The computer correlatesthe data it receives from the instrument-mounted sensors with thedigital map that was created from the preoperative tomographic scan. Thetomographic scan images are displayed on a video monitor along with anindicator (e.g., cross hairs or an illuminated dot, etc.) showing thereal time position of each surgical instrument relative to theanatomical structures shown in the scan images. In this manner, thesurgeon is able to know the precise position of each sensor-equippedinstrument by viewing the video monitor even if the surgeon is unable todirectly visualize the instrument itself at its current location withinthe body.

Examples of electromagnetic IGS systems that may be used in ENT andsinus surgery include the InstaTrak ENT™ systems available from GEMedical Systems, Salt Lake City, Utah. Other examples of electromagneticimage guidance systems that may be modified for use in accordance withthe present disclosure include but are not limited to the CARTO® 3System by Biosense-Webster, Inc., of Diamond Bar, Calif.; systemsavailable from Surgical Navigation Technologies, Inc., of Louisville,Colo.; and systems available from Calypso Medical Technologies, Inc., ofSeattle, Wash.

When applied to functional endoscopic sinus surgery (FESS), balloonsinuplasty, and/or other ENT procedures, the use of image guidancesystems allows the surgeon to achieve more precise movement andpositioning of the surgical instruments than can be achieved by viewingthrough an endoscope alone. This is so because a typical endoscopicimage is a spatially limited, 2-dimensional, line-of-sight view. The useof image guidance systems provides a real time, 3-dimensional view ofall of the anatomy surrounding the operative field, not just that whichis actually visible in the spatially limited, 2-dimensional, directline-of-sight endoscopic view. As a result, image guidance systems maybe particularly useful during performance of FESS, balloon sinuplasty,and/or other ENT procedures where a section and/or irrigation source maybe desirable, especially in cases where normal anatomical landmarks arenot present or are difficult to visualize endoscopically.

While several systems and methods have been made and used in ENTprocedures, it is believed that no one prior to the inventors has madeor used the invention described in the appended claims.

BRIEF DESCRIPTION OF THE DRAWINGS

While the specification concludes with claims which particularly pointout and distinctly claim the invention, it is believed the presentinvention will be better understood from the following description ofcertain examples taken in conjunction with the accompanying drawings, inwhich like reference numerals identify the same elements and in which:

FIG. 1A depicts a perspective view of an exemplary dilation instrumentassembly, with a guidewire in a proximal position, and with a dilationcatheter in a proximal position;

FIG. 1B depicts a perspective view of the dilation instrument assemblyof FIG. 1A, with the guidewire in a distal position, and with thedilation catheter in the proximal position;

FIG. 1C depicts a perspective view of the dilation instrument assemblyof FIG. 1A, with the guidewire in a distal position, with the dilationcatheter in a distal position, and with a dilator of the dilationcatheter in a non-dilated state;

FIG. 1D depicts a perspective view of the dilation instrument assemblyof FIG. 1A, with the guidewire in a distal position, with the dilationcatheter in the distal position, and with a dilator of the dilationcatheter in a dilated state;

FIG. 2 depicts a schematic view of an exemplary sinus surgery navigationsystem;

FIG. 3 depicts a perspective view of the head of a patient, withcomponents of the navigation system of FIG. 2 ;

FIG. 4 depicts a perspective view of an exemplary medical procedurechair, with an exemplary navigation component support assembly securedto the chair;

FIG. 5 depicts a perspective view of the navigation component supportassembly of FIG. 4 ;

FIG. 6 depicts the medical procedure chair of FIG. 4 , with arepresentation of a patient seated in the chair, and with an exemplaryalternative dilation catheter advanced toward the patient;

FIG. 7 depicts a side elevational view of the distal portion of thedilation catheter of FIG. 6 , including a navigation sensor and a forcesensor;

FIG. 8 depicts a schematic of an exemplary alternative sinus surgeryguidance system including the dilation catheter of FIG. 6 and a computerprocessor system;

FIG. 9 depicts a perspective view of the dilation instrument assembly ofFIG. 1A, with the dilation catheter of FIG. 6 slidably disposed therein,with the guidewire in a distal position, with the dilation catheter inthe distal position, and with a dilator of the dilation catheter in adilated state; and

FIG. 10 depicts a cross-sectional end view of the dilation catheter ofFIG. 6 , with the navigation sensor and force sensor positioned on a tipof the distal end.

The drawings are not intended to be limiting in any way, and it iscontemplated that various embodiments of the invention may be carriedout in a variety of other ways, including those not necessarily depictedin the drawings. The accompanying drawings incorporated in and forming apart of the specification illustrate several aspects of the presentinvention, and together with the description serve to explain theprinciples of the invention; it being understood, however, that thisinvention is not limited to the precise arrangements shown.

DETAILED DESCRIPTION

The following description of certain examples of the invention shouldnot be used to limit the scope of the present invention. Other examples,features, aspects, embodiments, and advantages of the invention willbecome apparent to those skilled in the art from the followingdescription, which is by way of illustration, one of the best modescontemplated for carrying out the invention. As will be realized, theinvention is capable of other different and obvious aspects, all withoutdeparting from the invention. Accordingly, the drawings and descriptionsshould be regarded as illustrative in nature and not restrictive.

It will be appreciated that the terms “proximal” and “distal” are usedherein with reference to a clinician gripping a handpiece assembly.Thus, an end effector is distal with respect to the more proximalhandpiece assembly. It will be further appreciated that, for convenienceand clarity, spatial terms such as “top” and “bottom” also are usedherein with respect to the clinician gripping the handpiece assembly.However, surgical instruments are used in many orientations andpositions, and these terms are not intended to be limiting and absolute.

It is further understood that any one or more of the teachings,expressions, versions, examples, etc. described herein may be combinedwith any one or more of the other teachings, expressions, versions,examples, etc. that are described herein. The following-describedteachings, expressions, versions, examples, etc. should therefore not beviewed in isolation relative to each other. Various suitable ways inwhich the teachings herein may be combined will be readily apparent tothose of ordinary skill in the art in view of the teachings herein. Suchmodifications and variations are intended to be included within thescope of the claims.

I. Overview of Exemplary Dilation Catheter System

FIGS. 1A-1D shows an exemplary dilation instrument assembly (10) thatmay be used to dilate the ostium of a paranasal sinus; to dilate someother passageway associated with drainage of a paranasal sinus; todilate a Eustachian tube; or to dilate some other anatomical passageway(e.g., within the ear, nose, or throat, etc.). Dilation instrumentassembly (10) of this example comprises a guidewire power source (12),an inflation source (14), an irrigation fluid source (16), and adilation instrument (20). In some versions, guidewire power source (12)comprises a source of light. In some other versions, guidewire powersource (12) is part of an IGS system as described below. In the presentexample, inflation source (14) comprises a source of saline. However, itshould be understood that any other suitable source of fluid (liquid orotherwise) may be used. Also in the present example, irrigation fluidsource (16) comprises a source of saline. Again, though, any othersuitable source of fluid may be used. It should also be understood thatflush fluid source (16) may be omitted in some versions.

Dilation instrument (20) of the present example comprise a handle body(22) with a guidewire slider (24), a guidewire spinner (26), and adilation catheter slider (28). Handle body (22) is sized and configuredto be gripped by a single hand of a human operator. Sliders (24, 28) andspinner (26) are also positioned and configured to be manipulated by thesame hand that grasps handle body (22). It should therefore beunderstood that dilation instrument (20) may be fully operated by asingle hand of a human operator.

A. Exemplary Guide Catheter

A guide catheter (60) extends distally from handle body (22). Guidecatheter (60) includes an open distal end (62) and a bend (64) formedproximal to open distal end (62). In the present example, dilationinstrument (20) is configured to removably receive several differentkinds of guide catheters (60), each guide catheter (60) having adifferent angle formed by bend (64). These different angles mayfacilitate access to different anatomical structures. Various examplesof angles and associated anatomical structures are described in one ormore of the references cited herein; while further examples will beapparent to those of ordinary skill in the art in view of the teachingsherein. Guide catheter (60) of the present example is formed of a rigidmaterial (e.g., rigid metal and/or rigid plastic, etc.), such that guidecatheter (60) maintains a consistent configuration of bend (64) duringuse of dilation instrument (20). In some versions, dilation instrument(20), is further configured to enable rotation of guide catheter (60),relative to handle body (22), about the longitudinal axis of thestraight proximal portion of guide catheter (60), thereby furtherpromoting access to various anatomical structures.

B. Exemplary Guidewire

Dilation instrument (30) further comprises a guidewire (30), which iscoaxially disposed in guide catheter (60). Guidewire slider (24) issecured to guidewire (30) such that translation of guidewire slider (24)relative to handle body (22) provides corresponding translation ofguidewire (30) relative to handle body (22). In particular, translationof guidewire slider (24) from a proximal position (FIG. 1A) to a distalposition (FIG. 1B) causes corresponding translation of guidewire (30)from a proximal position (FIG. 1A) to a distal position (FIG. 1B). Whenguidewire (30) is in a distal position, a distal portion of guidewire(30) protrudes distally from open distal end (62) of guide catheter(60). Guidewire spinner (26) is operable to rotate guidewire (30) aboutthe longitudinal axis of guidewire (30). Guidewire spinner (26) iscoupled with guidewire slider (24) such that guidewire spinner (26)translates longitudinally with guidewire slider (24).

In some versions, guidewire (30) includes a preformed bend formed justproximal to the distal end (32) of guidewire (30). In such versions, thepreformed bend and the rotatability provided via guidewire spinner (26)may facilitate alignment and insertion of distal end (32) into a sinusostium, Eustachian tube, or other passageway to be dilated. Also in someversions, guidewire (30) includes at least one optical fiber extendingto a lens or other optically transmissive feature in distal end (32).This optical fiber may be in optical communication with guidewire powersource (12), such that light may be communicated from guidewire powersource (12) to distal end (32). In such versions, guidewire (30) mayprovide transillumination through a patient's skin in order to providevisual feedback to the operator indicating that distal end (32) hasreached a targeted anatomical structure.

By way of example only, guidewire (30) may be configured in accordancewith at least some of the teachings of U.S. Pat. No. 9,155,492, thedisclosure of which is incorporated by reference herein. In someversions, guidewire (30) is configured similar to the Relieva LumaSentry™ Sinus Illumination System by Acclarent, Inc. of Irvine, Calif.In addition to, or as an alternative to, including one or more opticalfibers, guidewire (30) may include a sensor and at least one wire thatenables guidewire (30) to provide compatibility with an IGS system asdescribed in greater detail below. Other features and operabilities thatmay be incorporated into guidewire (30) will be apparent to those ofordinary skill in the art in view of the teachings herein.

C. Exemplary Dilation Catheter

Dilation instrument (30) further comprises a dilation catheter (40),which is coaxially disposed in guide catheter (60). Dilation catheterslider (28) is secured to dilation catheter (40) such that translationof dilation catheter slider (28) relative to handle body (22) providescorresponding translation of dilation catheter (40) relative to handlebody (22). In particular, translation of dilation catheter slider (28)from a proximal position (FIG. 1B) to a distal position (FIG. 1C) causescorresponding translation of dilation catheter (40) from a proximalposition (FIG. 1B) to a distal position (FIG. 1C). When dilationcatheter (40) is in a distal position, a distal portion of dilationcatheter (40) protrudes distally from open distal end (62) of guidecatheter (60). As can also be seen in FIG. 1C, a distal portion ofguidewire (30) protrudes distally from the open distal end of dilationcatheter (40) when guidewire (30) and dilation catheter are both indistal positions.

Dilation catheter (40) of the present example comprises a non-extensibleballoon (44) located just proximal to open distal end (42) of dilationcatheter (40). Balloon (44) is in fluid communication with inflationsource (14). Inflation source (14) is configured to communicate fluid(e.g., saline, etc.) to and from balloon (44) to thereby transitionballoon (44) between a non-inflated state and an inflated state. FIG. 1Cshows balloon (44) in a non-inflated state. FIG. 1D shows balloon (44)in an inflated state. In some versions, inflation source (14) comprisesa manually actuated source of pressurized fluid. In some such versions,the manually actuated source of pressurized fluid is configured andoperable in accordance with at least some of the teachings of U.S. Pub.No. 2014/0074141, entitled “Inflator for Dilation of AnatomicalPassageway,” published Mar. 13, 2014, issued as U.S. Pat. No. 9,962,530on May 8, 2018, the disclosure of which is incorporated by referenceherein. Other suitable configurations that may be used to provide asource of pressurized fluid will be apparent to those of ordinary skillin the art in view of the teachings herein.

While not shown, it should be understood that dilation catheter (40) mayinclude at least two separate lumens that are in fluid isolationrelative to each other. One lumen may provide a path for fluidcommunication between balloon (44) and inflation source (14). The otherlumen may provide a path to slidably receive guidewire (30).

While dilation catheter (40) of the present example is configured totransition between a non-dilated state and a dilated state based on thecommunication of fluid to and from balloon (44), it should be understoodthat dilation catheter (40) may include various other kinds ofstructures to serve as a dilator. By way of example only, balloon (44)may be replaced with a mechanical dilator in some other versions.Dilation catheter (40) may be constructed and operable in accordancewith any of the various references cited herein. In some versions,dilator catheter (40) is configured and operable similar to the RelievaUltirra® Sinus Balloon Catheter by Acclarent, Inc. of Irvine, Calif. Insome other versions, dilator catheter (40) is configured and operablesimilar to the Relieva Solo Pro™ Sinus Balloon Catheter by Acclarent,Inc. of Irvine, Calif. Other suitable variations of dilation catheter(40) will be apparent to those of ordinary skill in the art in view ofthe teachings herein.

D. Exemplary Irrigation Features

In some instances, it may be desirable to irrigate an anatomical site.For instance, it may be desirable to irrigate a paranasal sinus andnasal cavity after dilation catheter (40) has been used to dilate anostium or other drainage passageway associated with the paranasal sinus.Such irrigation may be performed to flush out blood, etc. that may bepresent after the dilation procedure. In some such cases, guide catheter(60) may be allowed to remain in the patient while guidewire (30) anddilation catheter (40) are removed. A dedicated irrigation catheter (notshown) may then be inserted into guide catheter (60) and coupled withirrigation fluid source (16) via tube (50), to enable irrigation of theanatomical site in the patient. An example of an irrigation catheterthat may be fed through guide catheter (60) to reach the irrigation siteafter removal of dilation catheter (60) is the Relieva Vortex® SinusIrrigation Catheter by Acclarent, Inc. of Irvine, Calif. Another exampleof an irrigation catheter that may be fed through guide catheter (60) toreach the irrigation site after removal of dilation catheter (40) is theRelieva Ultirra® Sinus Irrigation Catheter by Acclarent, Inc. of Irvine,Calif.

In some other versions, dilation catheter (40) includes an additionalirrigation lumen and an associated set of irrigation ports near distalend (42), such that dilation catheter (40) may be coupled withirrigation fluid source (16) via tube (50). Thus, a separate, dedicatedirrigation catheter is not necessarily required in order to provideirrigation.

By way of example only, irrigation may be carried out in accordance withat least some of the teachings of U.S. Pub. No. 2008/0183128, entitled“Methods, Devices and Systems for Treatment and/or Diagnosis ofDisorders of the Ear, Nose and Throat,” published Jul. 31, 2008, nowabandoned. Of course, irrigation may be provided in the absence of adilation procedure; and a dilation procedure may be completed withoutalso including irrigation. It should therefore be understood thatdilation fluid source (16) and tube (50) are merely optional.

E. Exemplary Variations

In the present example, guidewire (30) is coaxially disposed withindilation catheter (40), which is coaxially disposed within guidecatheter (60). In some other versions, guide catheter (60) is omittedfrom dilation instrument (20). In some such versions, a malleable guidemember is used to guide guidewire (30) and dilation catheter (40). Insome such versions, guidewire (30) is omitted and dilation catheter (40)is slidably disposed about the exterior of the internal malleable guidemember. In some other versions, guidewire (30) is slidably disposedabout the exterior of the internal malleable guide member; and dilationcatheter (40) is slidably disposed about the exterior of guidewire (30).In still other versions, guidewire (30) is slidably disposed within theinterior of the malleable guide member; and dilation catheter (40) isslidably disposed about the exterior of the malleable guide member.

By way of example only, versions of dilation instrument (20) thatinclude a malleable guide member may be constructed and operable inaccordance with at least some of the teachings of U.S. Pub. No.2016/0310714, entitled “Balloon Dilation System with Malleable InternalGuide,” published Oct. 27, 2016, issued as U.S. Pat. No. 10,137,285 onNov. 27, 2018, the disclosure of which is incorporated by referenceherein. As another merely illustrative example, versions of dilationinstrument (20) that include a malleable guide member may be constructedand operable in accordance with at least some of the teachings of U.S.patent application Ser. No. 14/928,260, entitled “Apparatus for BendingMalleable Guide of Surgical Instrument,” filed Oct. 30, 2015, issued asU.S. Pat. No. 10,137,286 on Nov. 27, 2018, the disclosure of which isincorporated by reference herein; and/or U.S. Pub. No. 2012/0071857,entitled “Methods and Apparatus for Treating Disorders of the Sinuses,”published Mar. 22, 2012, now abandoned, the disclosure of which isincorporated by reference herein.

It should be understood that the variations of dilation instrument (20)described below in the context of an IGS system may be incorporated intoversions of dilation instrument (20) having a malleable guide just likethe variations of dilation instrument (20) described below in thecontext of an IGS system may be incorporated into versions of dilationinstrument (20) having a rigid guide catheter (60).

Various examples below describe the use of an IGS system to providenavigation of instruments within a patient. In particular, variousexamples below describe how dilation instrument assembly (10) may bemodified to incorporate IGS system features.

However, it should also be understood that dilation instrument assembly(10) may be used in conjunction with conventional image guidanceinstruments, in addition to being used with IGS system components. Forinstance, dilation instrument assembly (10) may be used in conjunctionwith an endoscope, at least to provide initial positioning of guidecatheter (60) in a patient. By way of example only, such an endoscopemay be configured in accordance with at least some of the teachings ofU.S. Pub. No. 2010/0030031, now abandoned, the disclosure of which isincorporated by reference herein. Other suitable kinds of endoscopesthat may be used with the various versions of dilation instrumentassembly (10) described herein will be apparent to those of ordinaryskill in the art.

Other exemplary dilation catheter systems that may be used include thesystems described in U.S. Pat. Nos. 8,777,926 and 9,095,646, thedisclosures of which are incorporated by reference herein; and theRelieva Ultirra® Sinus Balloon Catheter system by Acclarent, Inc. ofIrvine, Calif.

II. Exemplary Image Guided Surgery Navigation System

FIG. 2 shows an exemplary GS navigation system (100) whereby an ENTprocedure may be performed using GS. In some instances, GS navigationsystem (100) is used during a procedure where dilation instrumentassembly (10) that may be used to dilate the ostium of a paranasalsinus; or to dilate some other anatomical passageway (e.g., within theear, nose, or throat, etc.). However, it should be understood that GSnavigation system (100) may be readily used in various other kinds ofprocedures.

In addition to or in lieu of having the components and operabilitydescribed herein GS navigation system (100) may be constructed andoperable in accordance with at least some of the teachings of U.S. Pat.Pub. No. 2007/0208252, entitled “Systems and Methods for PerformingImage Guided Procedures within the Ear, Nose, Throat and ParanasalSinuses,” published Sep. 6, 2007, now abandoned, the disclosure of whichis incorporated by reference herein; U.S. Pat. No. 8,702,626, entitled“Guidewires for Performing Image Guided Procedures,” issued Apr. 22,2014, the disclosure of which is incorporated by reference herein; U.S.Pat. No. 8,320,711, entitled “Anatomical Modeling from a 3-D Image and aSurface Mapping,” issued Nov. 27, 2012, the disclosure of which isincorporated by reference herein; U.S. Pat. No. 8,190,389, entitled“Adapter for Attaching Electromagnetic Image Guidance Components to aMedical Device,” issued May 29, 2012, the disclosure of which isincorporated by reference herein; U.S. Pat. No. 8,123,722, entitled“Devices, Systems and Methods for Treating Disorders of the Ear, Noseand Throat,” issued Feb. 28, 2012, the disclosure of which isincorporated by reference herein; and U.S. Pat. No. 7,720,521, entitled“Methods and Devices for Performing Procedures within the Ear, Nose,Throat and Paranasal Sinuses,” issued May 18, 2010, the disclosure ofwhich is incorporated by reference herein.

Similarly, in addition to or in lieu of having the components andoperability described herein, GS navigation system (100) may beconstructed and operable in accordance with at least some of theteachings of U.S. Pat. Pub. No. 2014/0364725, entitled “Systems andMethods for Performing Image Guided Procedures within the Ear, Nose,Throat and Paranasal Sinuses,” published Dec. 11, 2014, now abandoned,the disclosure of which is incorporated by reference herein; U.S. Pat.Pub. No. 2014/0200444, entitled “Guidewires for Performing Image GuidedProcedures,” published Jul. 17, 2014, now abandoned, the disclosure ofwhich is incorporated by reference herein; U.S. Pat. No. 9,198,736,entitled “Adapter for Attaching Electromagnetic Image GuidanceComponents to a Medical Device,” issued Dec. 1, 2015, the disclosure ofwhich is incorporated by reference herein; U.S. Pat. Pub. No.2011/0060214, entitled “Systems and Methods for Performing Image GuidedProcedures within the Ear, Nose, Throat and Paranasal Sinuses,”published Mar. 10, 2011, now abandoned, the disclosure of which isincorporated by reference herein; U.S. Pat. No. 9,167,961, entitled“Methods and Apparatus for Treating Disorders of the Ear Nose andThroat,” issued Oct. 27, 2015, the disclosure of which is incorporatedby reference herein; and U.S. Pat. Pub. No. 2007/0208252, entitled“Systems and Methods for Performing Image Guided Procedures within theEar, Nose, Throat and Paranasal Sinuses,” published Sep. 6, 2007, thedisclosure of which is incorporated by reference herein.

GS navigation system (100) of the present example comprises a set ofmagnetic field generators (122). Before a surgical procedure begins,field generators (122) are fixed to the head of the patient. As bestseen in FIG. 3 , field generators (122) are incorporated into a frame(120), which is clamped to the head of the patient. While fieldgenerators (122) are secured to the head of the patient in this example,it should be understood that field generators (122) may instead bepositioned at various other suitable locations and on various othersuitable structures. By way of example only, field generators (122) maybe mounted on an independent structure that is fixed to a table or chairon which the patient is positioned, on a floor-mounted stand that hasbeen locked in position relative to the head of the patient, and/or atany other suitable location(s) and/or on any other suitablestructure(s).

Field generators (122) are operable to generate an electromagnetic fieldaround the head of the patient. In particular, field generators (122)are operated so as to transmit alternating magnetic fields of differentfrequencies into a region in proximity to frame (120). Field generators(122) thereby enable tracking of the position of a navigation guidewire(130), or navigation dilation catheter (140), that is inserted into anasal sinus of the patient and in other locations within the patient'shead. Various suitable components that may be used to form and drivefield generators (122) will be apparent to those of ordinary skill inthe art in view of the teachings herein.

Navigation guidewire (130) may be used as a substitute for guidewire(30) described above, and may include a sensor (not shown) that isresponsive to movement within the fields generated by field generators(122). In particular, signals generated by the sensor of navigationguidewire (130) may be processed by processor (110) to determine thethree-dimensional location of navigation guidewire (130) within thepatient. Various suitable forms that the sensor may take will beapparent to those of ordinary skill in the art in view of the teachingsherein, particularly in view of several of the references that are citedherein in the context of GS navigation system (100). It should beunderstood that, when used as a substitute for guidewire (30) indilation instrument assembly (10), navigation guidewire (130) mayfacilitate navigation of instrumentation of dilation instrument assembly(10) within the patient during performance of a procedure to dilate theostium of a paranasal sinus; or to dilate some other anatomicalpassageway (e.g., within the ear, nose, or throat, etc.). It should alsobe understood that other components of dilation instrument assembly (10)may incorporate a sensor like the sensor of navigation guidewire (130),including but not limited to the exemplary alternative dilation catheter(140) described below.

GS navigation system (100) of the present example further comprises aprocessor (110), which controls field generators (122) and otherelements of GS navigation system (100). Processor (110) comprises aprocessing unit communicating with one or more memories. Processor (110)of the present example is mounted in a console (116), which comprisesoperating controls (112) that include a keypad and/or a pointing devicesuch as a mouse or trackball. A physician uses operating controls (112)to interact with processor (110) while performing the surgicalprocedure.

Console (116) also connects to other elements of system (100). Forinstance, as shown in FIG. 2 a coupling unit (132) is secured to theproximal end of navigation guidewire (130). Coupling unit (132) of thisexample is configured to provide wireless communication of data andother signals between console (116) and navigation guidewire (130). Insome versions, coupling unit (132) simply communicates data or othersignals from navigation guidewire (130) to console (116)uni-directionally, without also communicating data or other signals fromconsole (116). In some other versions, coupling unit (132) providesbidirectional communication of data or other signals between navigationguidewire (130) to console (116). While coupling unit (132) of thepresent example couples with console (116) wirelessly, some otherversions may provide wired coupling between coupling unit (132) andconsole (116). Various other suitable features and functionality thatmay be incorporated into coupling unit (132) will be apparent to thoseof ordinary skill in the art in view of the teachings herein.

Processor (110) uses software stored in a memory of processor (110) tocalibrate and operate system (100). Such operation includes drivingfield generators (122), processing data from navigational guidewire(130), processing data from operating controls (112), and drivingdisplay screen (114). The software may be downloaded to processor (110)in electronic form, over a network, for example, or it may,alternatively or additionally, be provided and/or stored onnon-transitory tangible media, such as magnetic, optical, or electronicmemory.

Processor (110) is further operable to provide video in real time viadisplay screen (114), showing the position of the distal end ofnavigational guidewire (130) in relation to a video camera image of thepatient's head, a CT scan image of the patient's head, and/or a computergenerated three-dimensional model of the anatomy within and adjacent tothe patient's nasal cavity. Display screen (114) may display such imagessimultaneously and/or superimposed on each other. Moreover, displayscreen (114) may display such images during the surgical procedure. Suchdisplayed images may also include graphical representations ofinstruments that are inserted in the patient's head, such asnavigational guidewire (130), such that the operator may view thevirtual rendering of the instrument at its actual location in real time.Such graphical representations may actually look like the instrument ormay be a much simpler representation such as a dot, crosshairs, etc. Byway of example only, display screen (114) may provide images inaccordance with at least some of the teachings of U.S. Pub. No.2016/0008083, entitled “Guidewire Navigation for Sinuplasty,” publishedJan. 14, 2016, issued as U.S. Pat. No. 10,463,242 on Nov. 5, 2019, thedisclosure of which is incorporated by reference herein. In the eventthat the operator is also using an endoscope, the endoscopic image mayalso be provided on display screen (114). The images provided throughdisplay screen (114) may help guide the operator in maneuvering andotherwise manipulating instruments within the patient's head.

In the present example, navigational guidewire (130) includes one ormore coils at the distal end of navigational guidewire (130). Such acoil serves as a sensor as referred to above. When such a coil ispositioned within an electromagnetic field generated by field generators(122), movement of the coil within that magnetic field may generateelectrical current in the coil, and this electrical current may becommunicated along the electrical conduit(s) in navigational guidewire(130) and further to processor (110) via coupling unit (132). Thisphenomenon may enable IGS navigation system (00) to determine thelocation of the distal end of navigational guidewire (130) within athree-dimensional space as will be described in greater detail below. Inparticular, processor (110) executes an algorithm to calculate locationcoordinates of the distal end of navigational guidewire (130) from theposition related signals of the coil(s) in navigational guidewire (130).

In some instances, navigational guidewire (130) is used to generate athree-dimensional model of the anatomy within and adjacent to thepatient's nasal cavity; in addition to being used to provide navigationfor dilation catheter system (100) within the patient's nasal cavity.Alternatively, any other suitable device may be used to generate athree-dimensional model of the anatomy within and adjacent to thepatient's nasal cavity before navigational guidewire (130) is used toprovide navigation for dilation catheter system (100) within thepatient's nasal cavity. By way of example only, a model of this anatomymay be generated in accordance with at least some of the teachings ofU.S. Pub. No. 2016/0310042, entitled “System and Method to MapStructures of Nasal Cavity,” published Oct. 27, 2016, issued as U.S.Pat. No. 10,362,965 on Jul. 30, 2019, the disclosure of which isincorporated by reference herein. Still other suitable ways in which athree-dimensional model of the anatomy within and adjacent to thepatient's nasal cavity may be generated will be apparent to those ofordinary skill in the art in view of the teachings herein. It shouldalso be understood that, regardless of how or where thethree-dimensional model of the anatomy within and adjacent to thepatient's nasal cavity is generated, the model may be stored on console(116). Console (116) may thus render images of at least a portion of themodel via display screen (114) and further render real-time video imagesof the position of navigational guidewire (130) in relation to the modelvia display screen (114).

III. Exemplary Support Assembly for Navigation System Components

Some medical procedures, including but not limited to medical proceduresthat are performed in the ear, nose, or throat of a patient (referred toherein as “ENT procedures”), may be performed while the patient issupported by a chair. As shown in FIGS. 2-3 , when an ENT procedure isperformed with the assistance of an IGS navigation system (100), it maybe necessary to position an array of field generators (122) around thepatient's head. In the example described above, field generators (122)are mounted to a frame (120), which is mounted to the patient's head. Itmay be desirable to instead position field generators (122) on a supportstructure that is not mounted to the patient's head. For instance, whenthe patient is seated in a chair, it may be desirable to have the fieldgenerators (122) supported by the structure of the chair rather thanbeing supported by the patient's head.

Conventional medical procedure chairs, including those designedparticularly for use in ENT procedures, may include several metalliccomponents in the headrest of the chair. While such headrests mayprovide adequate structural support for field generators (122), metalliccomponents in such headrests (and/or elsewhere within the chair) mayinterfere with the functioning or accuracy of IGS navigation system(100) if the metallic components are too close to field generators(122). It may therefore be desirable to rely on the chair tostructurally support field generators (122) while avoiding the risk ofmetallic features of the chair compromising the functioning or accuracyof IGS navigation system (100). Moreover, it may be desirable to providea field generator (122) support assembly that may be readily retrofittedto a conventional medical procedure chair, such that a consumer need notpurchase an entire new chair in order to obtain the supportfunctionality described above. In versions where the support assemblymay be retrofitted to a conventional medical procedure chair, it may bedesirable to enable an operator to accomplish such retrofitting withoutrequiring the use of tools such as screwdrivers, etc.

The following examples relate to support assemblies that may beretrofitted to a conventional medical procedure chair, relying on thechair itself (rather than the patient's head) to structurally supportIGS navigation system (100) components such as field generators (122),without the risk of any metallic components of the chair interferingwith the functioning or accuracy of IGS navigation system (100), andwithout requiring the use of separate tools in order to complete theretrofitting.

FIG. 4 shows an exemplary ENT procedure chair (200) with a supportassembly (300) mounted thereon and supporting a navigation systemcomponent (400). Chair (200) includes a base (202), a bottom support(204), a backrest (206), a pair of armrests (208), a headrest (210) anda footrest (212). Chair (200) is configured to seat a patient thereonsuch that support assembly (300) is positioned adjacent to the patient'shead. In particular, headrest (210) is configured to support the head ofa patient while the patient is seated on bottom support (204). Supportassembly (300) of this example includes a wedge-shaped body (301) thatis configured to rest against a front surface (not shown) of backrest(206). A frame (304) extends from and is secured to backrest (206). Asbest seen in FIG. 5 , frame (304) is generally shaped like a horseshoein this example and includes a plurality of integral field generators(306). Field generators (306) of this example are configured andoperable just like field generators (122) described above.

Frame (304) is configured to hold field generators (306) in a generallyhorseshoe-shaped arrangement about the head of the patient, withoutframe (304) contacting the patient's head. A cable (not shown) is incommunication with field generators (306) and thereby provides a conduitfor communication between field generators (306) and processor (110) ofIGS navigation system (100). Various features that may be used to securesupport assembly (300) to backrest (206) will be apparent to those ofordinary skill in the art in view of the teachings herein.

IV. Navigation and Force Sensing Dilation Catheter

In the example described above, with field generators (306) mounted toframe (304) and assembled to chair (200), it may be desirable to employan alternative dilation catheter in lieu of dilation catheter (40)described above. In particular, it may be desirable to use a variationof dilation catheter (40) that is configured and operable to providereal-time navigational data as the dilation catheter is advanced intothe paranasal sinus or some other anatomical passageway of a patient(e.g., within the ear, nose, or throat, etc.). Providing a dilationcatheter that may be used to dilate an anatomical passageway whilegenerating live feedback of the current location of the instrument maybe beneficial to aid an operator in guiding the instrument to the targetsite during various kinds of procedures. Incorporating navigation systemcomponents, such as sensors, onto the dilation catheter that areconfigured to communicate with IGS navigation system (100) describedabove may be desirable to accurately observe the position of thedilation catheter within the patient's head.

Incorporating force sensing components, through additional sensors, ontothe variation of dilation catheter (40) may be further desirable toobserve the force and/or resistance encountered by the dilation catheteras it is advanced through the anatomical passageway. In unison, thecombination of a navigation system sensor(s) and a force sensingsensor(s) on/in the dilation catheter may be beneficial to provide anoperator with live feedback that the operator may use to adjust theirmanipulation of the instrument.

The following description provides various examples of a dilationcatheter that incorporates navigation system components and forcesensing components that are configured to cooperatively communicate withIGS navigation system (100) to improve tracking the position of aninstrument that is inserted into a nasal cavity of the patient and inother locations within the patient's head. The navigation system andforce sensing components are configured to be responsive to movement ofthe dilation catheter in relation to the fields generated by fieldgenerators (306) such that the signals generated by the instrumentsensors may be processed by a processor to accurately determine thethree-dimensional location of the instrument within the patient.

It should be understood that the navigation system and force sensingcomponents described below may be readily used in conjunction with anyof the various navigation systems (100) and support assemblies (300)described above and in any of the various surgical procedures describedin the various references described herein. Other suitable ways in whichthe below-described navigation system components may be used will beapparent to those of ordinary skill in the art in view of the teachingsherein.

FIG. 6 shows a diagrammatic representation of a patient (P) seated onENT procedure chair (200) as described above, with a head (H) of patient(P) supported by headrest (342). In particular, head (H) of patient (P)is situated adjacent to support assembly (300) such that thehorseshoe-shaped frame (304) extends about head (H) of patient (P)without any field generator (306) contacting head (H) of patient (P).FIG. 6 further shows an exemplary alternative dilation catheter (140)that may be used as a substitute for dilation catheter (40) describedabove. As best seen in FIG. 7 , dilation catheter (140) comprises aballoon (144) and a navigation sensor (146) proximate to a distal end(142) of dilation catheter (140). Except as otherwise described below,dilation catheter (140), balloon (144), and navigation sensor (146) areconfigured and operable just like dilation catheter (40), balloon (44),and navigation sensor (136), respectively, described above. It should beunderstood that dilation catheter (140) of the present example may bereadily incorporated into system (100) described above. It should alsobe understood that, in many respects, dilation catheter (140) functionssubstantially similar to dilation catheter (40) described above, suchthat dilation catheter (140) is operable to be used in dilationinstrument assembly (10) and thus be coaxially received within guidecatheter (30).

In the present example, navigation sensor (146) is positioned along aportion of distal end (142), distally relative to balloon (144) andproximally relative to a tip end (143) of distal end (142). In thisinstance, navigation sensor (146) is configured to be responsive tomovement within the fields generated by field generators (122). Inparticular, signals generated by navigation sensor (146) of dilationcatheter (140) may be processed by processor (110) to determine thethree-dimensional location of dilation catheter (140) within thepatient. Various suitable forms that navigation sensor (146) may takewill be apparent to those of ordinary skill in the art in view of theteachings herein, particularly in view of several of the references thatare cited herein in the context of IGS navigation system (100). As willbe described in greater detail below, an alternate processor (150) maybe used to process the signals generated by navigation sensor (146) todetermine the three-dimensional location of dilation catheter (140)while simultaneously processing signals generated by a force sensor(148) to determine an amount of force applied against distal end (142)of dilation catheter (140).

In the present example, dilation catheter (140) includes one or morecoils at distal end (142), with the one or more coils serving as sensor(146) as referred to above. For instance, navigation sensor (146) maycomprise one or more conductive coils of wire, with at least one suchcoil being wrapped about the longitudinal axis of dilation catheter(140). When such a coil is positioned within an electromagnetic fieldgenerated by field generators (122, 306), movement of the coil withinthat magnetic field may generate electrical current in the coil, andthis electrical current may be communicated along the electricalconduit(s) in dilation catheter (140) and further to processor (150) viacoupling unit (152). This phenomenon may enable system (160) todetermine the location of distal end (142) of dilation catheter (140)within a three-dimensional space as will be described in greater detailbelow. In particular, processor (150) executes an algorithm to calculatelocation coordinates of distal end (142) from the position relatedsignals of the coil(s) in dilation catheter (140). Alternatively, sensor(146) may be comprised of other similar imaging modalities. By way ofexample only, sensor (146) includes an x-ray, electromagnetic,radio-frequency, ultrasound, radiation, optics, etc., or other varioussuitable modalities as will be apparent to those of ordinary skill inthe art.

When used as a substitute for dilation catheter (40) in dilationinstrument assembly (10), dilation catheter (140) may facilitatenavigation of instrumentation of dilation instrument assembly (10)within the patient during performance of a procedure to dilate theostium of a paranasal sinus; or to dilate some other anatomicalpassageway (e.g., within the ear, nose, or throat, etc.). It should alsobe understood that other components of dilation instrument assembly (10)may incorporate a sensor like navigation sensor (146) of dilationcatheter (140).

Dilation catheter (140) further includes a force sensor (148) alongdistal end (142) such that force sensor (148) is adjacent to balloon(144), tip end (143), and navigation sensor (146). Similar to navigationsensor (146), force sensor (148) is positioned distally relative toballoon (144) and proximally relative to tip end (143). Force sensor(146) is positioned along distal end (142) at an orientation relative tothe position of navigation sensor (146) such that force sensor (148) islocated in a similar position along distal end (142) that is separatefrom navigation sensor (146). The respective positions and orientationsof sensors (146, 148) are interchangeable such that sensors (146, 148)may be positioned along any portion of distal end (142). Other suitablepositions of sensors (146, 148) along distal end (142) will be apparentto those of ordinary skill in the art in view of the teachings herein.

Force sensor (148) is positioned on distal end (142) such that forcesensor (148) is configured to respond to a force applied against distalend (142) as an operator navigates dilation catheter (140) through theanatomical passageways of a patient. By way of example only, forcesensor (148) may comprise an electromechanical sensor that is operableto quantitively measure mechanical force changes at distal end (142)during the insertion of dilation catheter (140) into a patient's head.Signals generated by force sensor (148) of dilation catheter (140) maybe processed by a processor (150) to determine the real-time forcevalues experienced at distal end (142) while dilation catheter (140) isselectively maneuvered within a patient. As will be described in greaterdetail below, processor (150) is configured to perform interactive forcemeasurements from the data received by force sensor (148). In otherwords, force sensor (148) is operable to transmit measurements ofmechanical force applied to tip end (143) to processor (150) forprocessing and subsequent real-time display to an operator. Othersuitable ways in which data from force sensor (148) may be processed andused will be apparent to those of ordinary skill in the art in view ofthe teachings herein.

In some versions, force sensor (148) is configured to be deformable suchthat sensor (148) comprises a deformable surface adapted to deform inresponse to a physical force pushing against sensor (148). In suchversions, force sensor (148) may further include a detector operable todetect the deformation of the surface and thereby transmit the data fromdilation catheter (140) to processor (150). By way of example only, thedeformable surface of force sensor (148) may include a layer of elastic,deformable, or compressible material, or any other suitable material aswill be apparent to those of ordinary skill in the art. In versionswhere force sensor (148) includes an elastic material, the elasticmaterial may comprise an elastomer.

As shown in FIG. 8 , an exemplary IGS navigation system (160) includes aprocessor (150). It should be understood that system (160) of thepresent example is configured and operable just like system (100)described above, except for the difference of including processor (150)in place of processor (110). Processor (150) of this example isconfigured and operable just like processor (110) except that processor(150) is further operable to receive signals from force sensor (148), inaddition to signals from navigation sensor (146), and convert thesignals from force sensor (148) into data representing the forceencountered at distal end (142) of dilation catheter (140). Processor(150) is further configured to receive integrated anatomical informationsupplied from CT-scan images or other anatomical mapping data takenbefore a surgical procedure. Data from a preoperative CT scan or otheranatomical mapping procedure is downloaded into processor (150) suchthat an operator is able to ascertain, in three dimensions, the preciseposition of sensor (146), equipped onto dilation catheter (140), at anygiven point in time during the procedure. This information, coupled withthe visual observations provided through a standard endoscope, allows anoperator to carefully position dilation catheter (140) and guidewire(30) to avoid causing damage to a nerve or other critical structureswithin a patient.

The other components and operability of system (160) is consistent withthe teachings of system (100) described above. For example, a couplingunit (152) is configured to provide communication of data and othersignals between processor (150) and dilation catheter (140), similar tocoupling unit (132) described above. In this instance, however, couplingunit (152) further communicates data from force sensor (148) toprocessor (150). As described above, this communication of data orsignals from dilation catheter (140) to processor (150) may beunidirectional, without also communicating data or other signals fromprocessor (150). In some other versions, coupling unit (152) may providebidirectional communication of data or other signals between dilationcatheter (140) and processor (150). While coupling unit (152) of thepresent example couples with processor (150) through a wired coupling(154), some other versions may provide wireless communication betweencoupling unit (152) and processor (150). Various other suitable featuresand functionality that may be incorporated into coupling unit (152) willbe apparent to those of ordinary skill in the art in view of theteachings herein.

Processor (150) uses software stored in a memory of processor (150) tocalibrate and operate system (160) by driving field generators (306),processing data from dilation catheter (140), processing data fromoperating controls (156), and driving a display screen (158). Thesoftware may be downloaded to processor (150) in electronic form, over anetwork, for example, or it may, alternatively or additionally, beprovided and/or stored on non-transitory tangible media, such asmagnetic, optical, or electronic memory. Processor (150) is furtheroperable to provide real time force values via display screen (158),showing the force encountered by force sensor (148) of dilation catheter(140) in relation to the position of distal end (142) within a patient'shead.

As further seen in FIG. 8 , display screen (158) outputs the dataretrieved from force sensor (148), and processed by processor (150),into numerical values. By displaying real-time measurements of the forceexerted on distal end (142) as dilation catheter (140) is used in asurgical procedure, display screen (158) enables an operator to analyzethe current forces exhibited to thereby determine which direction toadvance dilation catheter (140). Although display screen (158) displaysthe force data measured in grams in the present example, it should beunderstood that display screen (158) is operable to convert and outputthe data processed from processor (150) into varying measurement units,including but not limited to, kilograms (kg), pounds (lbs), newtons (N),etc., or other units of measurement as will be apparent to those ofordinary skill in the art.

As further shown in FIG. 8 , display screen (158) is operable to furtherdisplay the data retrieved from force sensor (148) in various otherforms, a graphical representation. Although not shown, it should beunderstood that display screen (158) may display the data from forcesensor (148) in other suitable forms as will be apparent to those ofordinary skill in the art. For instance, when force sensor (148)encounters little or no resistive force, a force feedback portion ifdisplay screen (158) may be illuminated in green. When force sensor(148) encounters an intermediate range of resistive force, a forcefeedback portion if display screen (158) may be illuminated in yellow.When force sensor (148) encounters substantial resistive force, a forcefeedback portion if display screen (158) may be illuminated in red. Thecolors may progressively shift among these three colors as the forcetraverses a range of values. Other suitable ways in which display screen(158) may provide visual feedback relating to force encountered bydilation catheter (140), based on signals from force sensor (148), willbe apparent to those of ordinary skill in the art in view of theteachings herein.

Display screen (158) is operable to display the data retrieved fromforce sensor (148) simultaneously with the information received bynavigation sensor (146) during a live surgical procedure. Such displayedcontent may also include graphical representations of instruments thatare inserted in the patient's head, such as dilation catheter (140),such that the operator may view the virtual rendering of the instrumentat its actual location in real time. As described above, such graphicalrepresentations may actually look like the instrument or may be a muchsimpler representation such as a dot, crosshairs, etc. By way of exampleonly, display screen (158) may provide images in accordance with atleast some of the teachings of U.S. Pub. No. 2016/0008083, entitled“Guidewire Navigation for Sinuplasty,” published Jan. 14, 2016, issuedas U.S. Pat. No. 10,463,242 on Nov. 5, 2019, the disclosure of which isincorporated by reference herein. In the event that the operator is alsousing an endoscope, the endoscopic image may also be provided on displayscreen (158). The images and real-time force values provided throughdisplay screen (158) may help guide the operator in maneuvering andotherwise manipulating instruments within the patient's head.

In some instances, system (160) is operable to provide an operator withfeedback when processor (150) receives data from force sensor (148) anddetermines that the resistive contact force encountered at distal end(142) of dilation catheter (140) exceeds a predetermined threshold. Byway of example only, processor (150) may be configured to generate anaudio feedback in the form of a sound or audio alert to indicate to anoperator that the physical force exerted upon distal end (142) exceedsthe predetermined threshold. Other suitable forms of feedback may beprovided through system (160). By way of example only, system (160) maygenerate an optical feedback through display (158), such as adescriptive message, a lighting, or other visual cue as will be apparentto those of ordinary skill in the art. Alternatively, in some examplesdilation catheter (140) is configured to generate a tactile feedbackwhen force sensor (148) computers a force beyond the predeterminedthreshold. In this instance, a handle portion of dilation catheter (140)may be configured to vibrate to thereby indicate an alert to anoperator. Other various forms of feedback that will be suitable forsystem (160) to alert an operator will be apparent to those of ordinaryskill in the art in view of the teachings herein.

In use, dilation catheter (140) is coaxially disposed in guide catheter(60) as seen in FIG. 9 . Dilation catheter slider (28) is secured todilation catheter (140) such that translation of dilation catheterslider (28) relative to handle body (22) provides correspondingtranslation of dilation catheter (140) relative to handle body (22). Assimilarly shown in FIGS. 1B and 1C, translation of dilation catheterslider (28) from a proximal position to a distal position causescorresponding translation of dilation catheter (140) from a proximalposition (FIG. 1B) to a distal position (FIG. 9 ). When dilationcatheter (140) is in a distal position, distal end (142) of dilationcatheter (140) protrudes distally from open distal end (62) of guidecatheter (60). A distal portion of guidewire (30) also protrudesdistally from distal end (142) of dilation catheter (140) when guidewire(30) and dilation catheter (140) are both in distal positions.

With dilation catheter (140) in the distal position relative to guidecatheter (60), balloon (144), navigation sensor (146) and force sensor(148), all located adjacent to distal end (142), are extended beyondopen distal end (62). Similar to balloon (44) described above, balloon(144) is in fluid communication with inflation source (14), which isconfigured to communicate fluid (e.g., saline, etc.) to and from balloon(144) to thereby transition balloon (144) between a non-inflated state(FIG. 1C) and an inflated state (FIG. 9 ). In this instance, an operatormay monitor display screen (158) to navigate and view the location ofdistal end (142) and balloon (144) within a patient. Simultaneously, anoperator may observe the pressure or force applied against distal end(142) of dilation catheter (140) as dilation catheter (140) ismaneuvered within a patient's head and adjacent to various anatomicalstructures therein. Having the navigational and force measurementsreadily available, an operator may better determine when and/or where toinflate balloon (144). While not shown, it should be understood thatdilation catheter (140) may further include at least two separate lumensthat are in fluid isolation relative to each other. One lumen mayprovide a path for fluid communication between balloon (144) andinflation source (14). The other lumen may provide a path to slidablyreceive guidewire (30) therein.

While dilation catheter (140) of the present example is configured totransition between a non-dilated state and a dilated state based on thecommunication of fluid to and from balloon (144), it should beunderstood that dilation catheter (140) may include various other kindsof structures to serve as a dilator. By way of example only, balloon(144) may be replaced with a mechanical dilator in some other versions.Dilation catheter (140) may be constructed and operable in accordancewith any of the various references cited herein. In some versions,dilator catheter (140) is configured and operable similar to the RelievaUltirra™ Sinus Balloon Catheter by Acclarent, Inc. of Irvine, Calif. Insome other versions, dilator catheter (140) is configured and operablesimilar to the Relieva Solo Pro™ Sinus Balloon Catheter by Acclarent,Inc. of Irvine, Calif. Other suitable variations of dilation catheter(140) will be apparent to those of ordinary skill in the art in view ofthe teachings herein.

In some other versions, navigation sensor (146) and force sensor (148)are positioned on tip end (143) of distal end (142), as seen in FIG. 10. In this instance, rather than sensors (146, 148) being located alongdistal end (142) and just proximal to tip end (143), sensors (146, 148)are positioned directly at tip end (143). In this instance, both sensors(146, 148) are directed toward the same direction, distal to tip end(143), rather than in varying directions about distal end (142). Havingsensors (146, 148) facing a single direction from distal end (142) maybe desirable to clearly indicate to an operator the direction in whichtip end (143) is facing, through the data transmitted by navigationsensor (146), and the direction which the measured force is encounteredfrom, through the data transmitted by force sensor (148). As furtherseen in FIG. 10 , distal end (142) further includes a lumen (141) sizedand shaped to slidably receive guidewire (30) therein. It should beunderstood that the position and orientations of sensors (146, 148) andlumen (141) on tip end (143) may vary from those depicted in FIG. 10 .Other various suitable positions and orientations of sensors (146, 148)and lumen (141) on tip end (143) will be apparent to those of ordinaryskill in the art in view of the teachings herein.

While dilation catheter (140) is described above as being used withguidewire (30), dilation catheter (140) may alternatively be used withguidewire (130). In such scenarios, system (160) may provide theoperator with feedback indicating the position of guidewire (130) in thehead (H) of the patient (P) and also feedback indicating the position ofdilation catheter (140) in the head (H) of the patient (P).

V. Exemplary Combinations

The following examples relate to various non-exhaustive ways in whichthe teachings herein may be combined or applied. It should be understoodthat the following examples are not intended to restrict the coverage ofany claims that may be presented at any time in this application or insubsequent filings of this application. No disclaimer is intended. Thefollowing examples are being provided for nothing more than merelyillustrative purposes. It is contemplated that the various teachingsherein may be arranged and applied in numerous other ways. It is alsocontemplated that some variations may omit certain features referred toin the below examples. Therefore, none of the aspects or featuresreferred to below should be deemed critical unless otherwise explicitlyindicated as such at a later date by the inventors or by a successor ininterest to the inventors. If any claims are presented in thisapplication or in subsequent filings related to this application thatinclude additional features beyond those referred to below, thoseadditional features shall not be presumed to have been added for anyreason relating to patentability.

Example 1

A system comprising: (a) a dilation catheter, wherein the dilationcatheter includes: (i) a proximal end, (ii) a distal end, (iii) adilator, wherein the dilator is positioned proximal to the distal end,wherein the dilator is configured to transition between a non-dilatedconfiguration and a dilated configuration, (iii) a navigation sensorpositioned distal to the dilator, wherein the navigation sensor isconfigured to cooperate with a guidance system and thereby providesignals indicating a position of the dilation catheter inthree-dimensional space, and (iv) a force sensor positioned distal tothe dilator, wherein the force sensor is configured to provide signalsindicating a force encountered by the force sensor; and (b) a guidemember, wherein the dilation catheter is configured to slide relative tothe guide member, wherein a distal portion of the guide member is sizedand configured to fit in a nasal cavity of a patient.

Example 2

The system of Example 1, wherein the navigation sensor comprises anelectromagnetic sensor.

Example 3

The system of any one or more of Examples 1 through 2, furthercomprising a sensor coupling unit, a computer processor, and a videodisplay monitor.

Example 4

The system of Example 3, wherein the coupling unit is operable toreceive the signals transmitted by the navigation sensor and forcesensor, wherein the coupling unit is further operable to communicate thesignals from the sensors to the computer processor.

Example 5

The system of Example 4, wherein the coupling unit is in wiredcommunication with the computer processor.

Example 6

The system of Example 4, wherein the coupling unit is in wirelesscommunication with the computer processor.

Example 7

The system of any one or more of Examples 4 through 6, wherein thecomputer processor is operable to receive the signals transmitted by thecoupling unit and convert the signals into data.

Example 8

The system of Example 7, wherein the video display monitor is operableto graphically display the data converted by the computer processor,wherein the video display is further operable to display an anatomicalimage of the paranasal sinus.

Example 9

The system of any one or more of Examples 7 through 8, wherein thecomputer processor is operable to generate at least one of numericalfeedback, graphical feedback, or audio feedback.

Example 10

The system of any one or more of Examples 1 through 9, furthercomprising a transmitter, wherein the transmitter is operable totransmit a signal that is sensed by the navigation sensor.

Example 11

The system of Example 10, wherein the transmitter comprises a generatoroperable to generate an electromagnetic field.

Example 12

The system of any one or more of Examples 1 through 11, wherein theguide member comprises a guide catheter.

Example 13

The system of Example 12, wherein the guide catheter defines a lumen,wherein the dilation catheter is slidably disposed in the lumen of theguide catheter.

Example 14

The system of Example 13, further comprising a guidewire, wherein thedilation catheter defines a lumen, wherein the guidewire is slidablydisposed in the lumen of the dilation catheter.

Example 15

The system of any one or more of Examples 1 through 13, wherein theguide member comprises a guidewire.

Example 16

The system of Example 15, wherein the guidewire comprises a navigationsensor, wherein the navigation sensor of the guidewire is configured tocooperate with a guidance system and thereby provide signals indicatinga position of the guidewire in three-dimensional space.

Example 17

A system comprising: (a) a dilation catheter, wherein the dilationcatheter includes: (i) a proximal end, (ii) a distal end, (iii) aballoon dilator, wherein the balloon dilator is positioned proximal tothe distal end, wherein the balloon dilator is configured to inflatefrom non-dilated configuration to a dilated configuration, (iii) a firstsensor positioned distal to the dilator, and (iv) a second sensorpositioned distal to the dilator; and (b) a guide member, wherein thedilation catheter is configured to slide relative to the guide member,wherein a distal portion of the guide member is sized and configured tofit in a nasal cavity of a patient; and (c) a processor, wherein theprocessor is configured to determine the position of the dilator inthree-dimensional spaced based on a position signal from the firstsensor, wherein the processor is further configured to determine a forceexerted against the dilation catheter based on a force signal from thesecond sensor.

Example 18

The system of Example 17, further comprising at least oneelectromagnetic field generator, wherein the first sensor is configuredto generate the position signal in response to movement of the firstsensor within an electromagnetic field generated by the electromagneticfield generator.

Example 19

The system of any one or more of Examples 17 through 18, furthercomprising a display in communication with the processor, wherein thedisplay is configured to provide visual feedback indicative of theposition of the dilator in three-dimensional space, wherein the displayis further configured to provide visual feedback indicative of forceexerted against the dilation catheter.

Example 20

A method of navigating a medical instrument in a paranasal sinus using aguidance system, the guidance system comprising a navigation sensor, aforce sensor, a processor, and a display, the method comprising: (a)advancing the medical instrument into a nasal cavity of a patient; (b)observing a position feedback indicator on a display to monitor thelocation of the medical instrument in the nasal cavity of the patient,wherein the position feedback indicator is rendered based on data fromthe navigation sensor; (c) observing a force feedback indicator on adisplay to monitor forces exerted against the medical instrument in thenasal cavity of the patient, wherein the force feedback indicator isrendered based on data from the force sensor; and (d) maneuvering themedical instrument in the nasal cavity in accordance with the observedfeedback indicators to thereby position the medical instrument at atarget site.

VI. Miscellaneous

In some versions, support assembly (300) is formed entirely ofnon-metallic materials. In addition, the materials used to form supportassembly (300) may be configured to allow easily cleaning of supportassembly (300) with disinfectants, such that the disinfectants do notdamage the materials forming support assembly (300). The materials usedto form any portion(s) of support assembly (300) that may come inprolonged contact with the patient's skin may also be biocompatible andcomply with cytoxicity, sensitization, and irritation tests. Varioussuitable materials that may be used to form support assembly (300)meeting at least some of the above criteria will be apparent to those ofordinary skill in the art in view of the teachings herein.

By way of further example only, the entire weight of support assembly(300), without frame (304) and field generators (306), may be less thanapproximately 50 kg. Support assembly (300) may also be configured toprovide sufficient mechanical support to enable the combination of chair(200) and support assembly (300) to support a patient weighing up toapproximately 150 kg.

While chair (200) is provided in the examples described herein, theteachings herein may be readily used in combination with various otherkinds of chairs, including but not limited to various other kinds ofchairs that are designed for use in ENT procedures. Support assembly(300) may thus accommodate various kinds of backrest widths and otherstructural variations among chairs.

It should be understood that any of the examples described herein mayinclude various other features in addition to or in lieu of thosedescribed above. By way of example only, any of the examples describedherein may also include one or more of the various features disclosed inany of the various references that are incorporated by reference herein.

It should be understood that any one or more of the teachings,expressions, embodiments, examples, etc. described herein may becombined with any one or more of the other teachings, expressions,embodiments, examples, etc. that are described herein. Theabove-described teachings, expressions, embodiments, examples, etc.should therefore not be viewed in isolation relative to each other.Various suitable ways in which the teachings herein may be combined willbe readily apparent to those of ordinary skill in the art in view of theteachings herein. Such modifications and variations are intended to beincluded within the scope of the claims.

It should be appreciated that any patent, publication, or otherdisclosure material, in whole or in part, that is said to beincorporated by reference herein is incorporated herein only to theextent that the incorporated material does not conflict with existingdefinitions, statements, or other disclosure material set forth in thisdisclosure. As such, and to the extent necessary, the disclosure asexplicitly set forth herein supersedes any conflicting materialincorporated herein by reference. Any material, or portion thereof, thatis said to be incorporated by reference herein, but which conflicts withexisting definitions, statements, or other disclosure material set forthherein will only be incorporated to the extent that no conflict arisesbetween that incorporated material and the existing disclosure material.

Versions of the devices disclosed herein can be designed to be disposedof after a single use, or they can be designed to be used multipletimes. Versions may, in either or both cases, be reconditioned for reuseafter at least one use. Reconditioning may include any combination ofthe steps of disassembly of the device, followed by cleaning orreplacement of particular pieces, and subsequent reassembly. Inparticular, versions of the device may be disassembled, and any numberof the particular pieces or parts of the device may be selectivelyreplaced or removed in any combination. Upon cleaning and/or replacementof particular parts, versions of the device may be reassembled forsubsequent use either at a reconditioning facility, or by a surgicalteam immediately prior to a surgical procedure. Those skilled in the artwill appreciate that reconditioning of a device may utilize a variety oftechniques for disassembly, cleaning/replacement, and reassembly. Use ofsuch techniques, and the resulting reconditioned device, are all withinthe scope of the present application.

By way of example only, versions described herein may be processedbefore surgery. First, a new or used instrument may be obtained and ifnecessary cleaned. The instrument may then be sterilized. In onesterilization technique, the instrument is placed in a closed and sealedcontainer, such as a plastic or TYVEK bag. The container and instrumentmay then be placed in a field of radiation that can penetrate thecontainer, such as gamma radiation, x-rays, or high-energy electrons.The radiation may kill bacteria on the instrument and in the container.The sterilized instrument may then be stored in the sterile container.The sealed container may keep the instrument sterile until it is openedin a surgical facility. A device may also be sterilized using any othertechnique known in the art, including but not limited to beta or gammaradiation, ethylene oxide, or steam.

Having shown and described various versions of the present invention,further adaptations of the methods and systems described herein may beaccomplished by appropriate modifications by one of ordinary skill inthe art without departing from the scope of the present invention.Several of such potential modifications have been mentioned, and otherswill be apparent to those skilled in the art. For instance, theexamples, versions, geometrics, materials, dimensions, ratios, steps,and the like discussed above are illustrative and are not required.Accordingly, the scope of the present invention should be considered interms of the following claims and is understood not to be limited to thedetails of structure and operation shown and described in thespecification and drawings.

We claim:
 1. An ENT instrument comprising: (a) a proximal end; (b) adistal end having a tip; (c) a navigation sensor positioned proximal tothe tip of the distal end, wherein the navigation sensor is configuredto cooperate with a guidance system and thereby provide signalsindicating a position of the ENT instrument in three-dimensional space,wherein the navigation sensor is spaced apart from the tip of the distalend by a first distance; and (d) a force sensor positioned proximal tothe tip of the distal end, wherein the force sensor is configured toprovide signals indicating a force encountered by the force sensor,wherein the force sensor is spaced apart from the tip of the distal endby the first distance.
 2. The ENT instrument of claim 1, wherein thenavigation sensor comprises an electromagnetic sensor.
 3. A systemcomprising the ENT instrument of claim 1, a sensor coupling unit, acomputer processor, and a video display monitor.
 4. The system of claim3, wherein the coupling unit is operable to receive the signalstransmitted by the navigation sensor and force sensor, wherein thecoupling unit is further operable to communicate the signals from thesensors to the computer processor.
 5. The system of claim 4, wherein thecoupling unit is in wired communication with the computer processor. 6.The system of claim 4, wherein the computer processor is operable toreceive the signals transmitted by the coupling unit and convert thesignals into data.
 7. The system of claim 6, wherein the video displaymonitor is operable to graphically display the data converted by thecomputer processor, wherein the video display is further operable todisplay an anatomical image of the paranasal sinus.
 8. The system ofclaim 6, wherein the computer processor is operable to generate at leastone of numerical feedback, graphical feedback, or audio feedback.
 9. Thesystem of claim 1, further comprising a balloon dilator positioned nearthe distal end.
 10. A system comprising the ENT instrument of claim 1and a transmitter, wherein the transmitter is operable to transmit asignal that is sensed by the navigation sensor.
 11. The system of claim10, wherein the transmitter comprises a generator operable to generatean electromagnetic field.
 12. A system comprising the ENT instrument ofclaim 1 and a guide member, wherein the ENT instrument is configured toslide relative to the guide member, wherein a distal portion of theguide member is sized and configured to fit in a nasal cavity of apatient, wherein the guide member comprises a guide catheter.
 13. Thesystem of claim 12, wherein the guide catheter defines a lumen, whereinthe ENT instrument is slidably disposed in the lumen of the guidecatheter.
 14. The system of claim 13, further comprising a guidewire,wherein the ENT instrument defines a lumen, wherein the guidewire isslidably disposed in the lumen of the ENT instrument.
 15. A systemcomprising the ENT instrument of claim 1 and a guide member, wherein theENT instrument is configured to slide relative to the guide member,wherein a distal portion of the guide member is sized and configured tofit in a nasal cavity of a patient, wherein the guide member comprises aguidewire.
 16. The system of claim 15, wherein the guidewire comprises anavigation sensor, wherein the navigation sensor of the guidewire isconfigured to cooperate with a guidance system and thereby providesignals indicating a position of the guidewire in three-dimensionalspace.
 17. A system comprising: (a) an ENT instrument, wherein the ENTinstrument includes: a proximal end, (ii) a distal end having a tip,(iii) a first sensor positioned proximal to the tip of the distal endand directed toward a first direction distal to the distal end, and (iv)a second sensor positioned proximal to the tip of the distal end anddirected toward the first direction; and (b) a processor, wherein theprocessor is configured to determine the position of the ENT instrumentin three-dimensional spaced based on a position signal from the firstsensor, wherein the processor is further configured to determine a forceexerted against the ENT instrument based on a force signal from thesecond sensor.
 18. The system of claim 17, further comprising at leastone electromagnetic field generator, wherein the first sensor isconfigured to generate the position signal in response to movement ofthe first sensor within an electromagnetic field generated by theelectromagnetic field generator.
 19. The system of claim 17, furthercomprising a display in communication with the processor, wherein thedisplay is configured to provide visual feedback indicative of theposition of the ENT instrument in three-dimensional space, wherein thedisplay is further configured to provide visual feedback indicative offorce exerted against the ENT instrument.
 20. A method of navigating amedical instrument in a paranasal sinus using a guidance system, theguidance system comprising a navigation sensor, a force sensor, aprocessor, and a display, the method comprising: (a) advancing themedical instrument into a nasal cavity of a patient; (b) observing aposition feedback indicator on a display to monitor the location of themedical instrument in the nasal cavity of the patient, wherein theposition feedback indicator is rendered based on data from thenavigation sensor, wherein the position feedback indicator indicates afirst direction in which a distal end of the medical instrument isfacing; and (c) observing a force feedback indicator on a display tomonitor forces exerted against the medical instrument in the nasalcavity of the patient, wherein the force feedback indicator is renderedbased on data from the force sensor, wherein the force feedbackindicator indicates a second direction in which the monitored forces areexerted from.